Clinical Trial Details

Overview

Research Study Summary

Coping With Depression in Parkinson's Disease

Purpose

Dr. Roseanne Dobkin at the Robert Wood Johnson Medical School in New Jersey is conducting a 10-week treatment study of depression in PD. The study treatment does not involve medication and helps people to change thinking patterns and behaviors that may be related to depression. Participation may take place over the phone for those who are unable to travel.

All research care including an extensive psychiatric evaluation is provided at no cost to those who qualify. A friend, family member, or significant other will also be asked to participate in the study. Participants are paid $20.00 for each study evaluation.

Persons with PD Inclusion Criteria:

Confirmed diagnosis of PD with no significant motor fluctuations or dementia.

Willingness to ask a family member or friend, with whom the patient has regular contact, to be involved in treatment.

Patients will be allowed to remain on antidepressant medications that have been stabilized (e.g., no dose changes) for at least 6 weeks prior to screening provided that they do not have plans to change these medications while in the study.

Patients will be allowed to remain on sedative-hypnotics or anxiolytics that have been stabilized for at least 4 weeks prior to screening. Patients who are taking these medications at screening and qualify for participation will be asked to remain on a stable course of these medications throughout the trial.

Taking a stable dose of dopaminergic replacement therapy for at least one month

Caregiver Inclusion Criteria:

Ages 25 to 85

Daily contact with a friend, family member, or spouse with depression and PD *MMSE > 26 [Mini Mental Status Exam score of greater than 26 (i.e., no signs of significant memory impairment)].

Persons with PD Exclusion Criteria:

DSM-IV criteria for a psychotic disorder, bipolar disorder, organic brain syndrome, or psychoactive substance dependence or abuse (Nicotine or caffeine dependence is allowed). Other psychiatric co-morbidity is not exclusionary as long as the depressive disorder is primary.

Active suicidal ideation.

An unstable major medical condition that would interfere with the study.

Plans to engage in additional psychotherapy during the study (PD support group is ok).

A diagnosis of dementia, defined as above.

Significant motor fluctuations, defined as above; mild end of dose wearing off is allowed.

Patients unwilling or unable to maintain a stable dose of dopaminergic replacement therapy during the trial.

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